The effect of electrical stimuration using
neuromuscular transmission monitor at unilateral HT7 acupoint on preventing emergence agitation in children.

Acronym

The effect of electrical stimuration at unilateral HT7 acupoint on preventing emergence agitation in children.

Scientific Title

The effect of electrical stimuration using
neuromuscular transmission monitor at unilateral HT7 acupoint on preventing emergence agitation in children.

Scientific Title:Acronym

The effect of electrical stimuration at unilateral HT7 acupoint on preventing emergence agitation in children.

Region

Japan

Condition

Condition

Pediatric patients who are scheduled to undergo surgery under general anesthesia.

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

Aim of our study is to evaluate the effect of electrical stimulation using neuromuscular transmitter monitoring device(NTM) to the HT7 acupoint for preventing emergence agitation in pediatric patients by double-blind, randomized controlled study.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

Incidence of emergence agitation under general anesthesia with sevoflurane

Key secondary outcomes

Severity of emergence agitation,recovery time,incidence pf PONV, incidence of other adverce effect, and rescuedrug use for the emergence agitation

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

HT7 stimulation group:
We plan to stimulate unilateral(Right side) HT7 acupoint using Neuromuscular transmission monitor(TOF watch).
Single-teitch stimulation with 1Hz(over 0.2 ms, at a constant current of 50 mA)was applied for the group throughout operation.

Interventions/Control_2

Control group:
The neuromuscular transmission monitor electrode attachments are placced on all subject at Right side HT7 acupoint, but electrical stimulation is not applied.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

18

months-old

<=

Age-upper limit

96

months-old

>=

Gender

Male and Female

Key inclusion criteria

ASA 1 or 2
Patients who are scheduled to undergo surgery under general anesthesia with sevoflurane

Key exclusion criteria

Children with developmental delay,
psychological or neurological disorders,
abnormal airway,
use ofpsychiatric or sadative medication
or reactive airway disease are excluded.